To compare the effects on the APC- (Activated Protein C) resistance ratio (ETP-[endogenous throbin potential] based) between the pivotal phase III NOMAC-E2 batch and a commercial NOMAC-E2 batchTo compare the effects on all other metabolic parameters…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
anticonceptie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To compare the effects on the APC- (Activated Protein C) resistance ratio
(ETP-[endogenous throbin potential] based) between the pivotal phase III
NOMAC-E2 batch and a commercial NOMAC-E2 batch.
Secondary outcome
Compare effect on all other metabolic parameters of two NOMAC-E2 batches:
hemostasis parameters, lipids and SHBG
Compare effect on metabolic parameters (as descibed above) between the two
NOMAC-E2 batches and LNG-EE
General safety: decreased libido, depression/deppressed mood, altered mood,
headache, migraine, nausea, acne, breast pain, withdrawal bleeding irregular,
metrorrhagia, increased weight, routine lab parameters, vital signs, (serious)
adverse events
Background summary
Results from the Phase IIIa clinical development program showed that NOMAC-E2
has a robust contraceptive efficacy, a stable vaginal bleeding profile, good
overall safety and tolerability, and less pronounced effects on metabolic
parameters than seen with a traditional levonorgestrel-ethinylestradiol
(LNG-EE) contraceptive pill.
After production of the two pivotal phase III batches, a number of changes
within CMC development were made for the intended commercial production of
NOMAC-E2. The purpose of this trial is to compare the safety data, specifically
the effect on metabolic parameters, between a batch prepared using the
commercial drug manufacturing process and one of the phase III pivotal clinical
batches. The COC Microgynon®, containing 150 µg LNG and 30 µg EE, is used as an
internal reference, because it is the standard to be included in hemostatic
trials according to the relevant EMEA guideline. LNG-EE was also used in the
previous metabolic trial with NOMAC-E2.
Study objective
To compare the effects on the APC- (Activated Protein C) resistance ratio
(ETP-[endogenous throbin potential] based) between the pivotal phase III
NOMAC-E2 batch and a commercial NOMAC-E2 batch
To compare the effects on all other metabolic parameters between the pivotal
phase III NOMAC-E2 batch and a commercial NOMAC-E2 batch
To compare the effects on metabolic parameters between both NOMAC-E2 batches
and a monophasic COC containing 150 µg LNG and 30 µg EE;
To evaluate general safety.
Study design
This is a randomized, open-label, parallel-group, multicenter, comparative
trial of two NOMAC-E2 batches (pivotal phase III and commercial batch) and
LNG-EE in healthy women.
Intervention
NOMAC-E2 pivotal phase III batch and commercial batch (2.5 mg NOMAC and 1.5 mg
E2) will be taken daily for three cycles of 28 days, each consisting of 24
NOMAC-E2 tablets and 4 placebo tablets.
LNG-EE (150 µg levonorgestrel-30µg ethynyl estradiol) will be taken daily for
three cycles of 28 days, each consisting of 21 LNG-EE tablets and 7 placebo
tablets.
Study burden and risks
At screening and at follow-up: physical, breast and gynecological examination,
cervical smear (only at screening), blood sampling
Two months washout of contraceptives combined with condom use before start
trial medication.
Home pregnancy test before first tablet intake
Daily diary entries from the day of first tablet intake
Visit 2, 3 blood sampling
Walmolen 1
3994 DL Houten
NL
Walmolen 1
3994 DL Houten
NL
Listed location countries
Age
Inclusion criteria
1. Each subject must be female and in good physical and mental health;
2. Each subject must be between 18 and 50 years (extremes included) of age at screening;
3. Each subject must have a body mass index between 17and 29 kg/m2 (extremes included)
Exclusion criteria
1. Any contraindication for contraceptive steroids;
2. An abnormal cervical smear (i.e. dysplasia, cervical intraepithelial neoplasia (CIN), squamous intraepithelial lesion (SIL), carcinoma in situ, invasive carcinoma) at screening;
3. Present use or use within 2 months prior to screening of any hormonal treatment including sex hormones (other than contraceptives), insulin, thyroid and corticosteroid hormones (with the exception of local dermatological use)
4. Present use or use within 2 months prior to starting trial medication of hepatic-enzyme inducing medications that may affect the bioavailability of sex steroids, lipid-lowering drugs, or anticoagulants.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-017288-40-NL |
| CCMO | NL30926.056.10 |